jueves, 10 de mayo de 2018

Trump’s 'America First' agenda on drug pricing could backfire around the world

He’s vowing to take on drug prices at home — but they could go up abroad

By SARAH KARLIN-SMITH and SARAH WHEATON

President Donald Trump wants Americans to get lower prices for medicines — and the rest of the world may pay for it.

His
"America First" message on drugs at home, coupled with
pro-pharmaceutical industry policies abroad, could lead to higher costs
for patients around the world — without making drugs more affordable for
those in the U.S.

Trump on Friday plans to deliver his
long-promised speech on how to lower drug costs, addressing an industry
he has in the past accused of "getting away with murder." Global health
officials worry he will also target practices that keep medicines
affordable in other countries.

Amid rising trade tensions
between the U.S. and key trading partners, Trump and top administration
officials have repeatedly blamed high U.S. prices in part on foreign
countries that take advantage of the significant U.S. investment in medical research
without paying their fair share. Many nations, including wealthy
European ones, negotiate or regulate drug prices to keep them lower than
what Americans typically pay.

“As part of President Trump’s
bold plan to put American patients first, HHS is focused on solving a
number of the problems that plague drug markets, including … foreign
governments free-riding off of American investment in innovation,”
Health and Human Services Secretary Alex Azar recently said.

He added that high drug prices can leave crucial medicines out of reach.

“There's
little difference for a sick patient between a miracle cure that hasn't
been discovered and one that is too expensive to use,” said Azar, a
former executive at Eli Lilly, which has received its share of criticism
for raising the price of medicines, including insulin.

Foreign
governments and international advocates are struggling to reconcile
Trump’s dual messages. He is making a populist call for affordability,
but at the same time U.S. diplomats have been defending the industry’s
prerogatives more than ever in trade negotiations and international
gatherings.

Many European experts view the policies he is
crafting on trade, patents, transparency and intellectual property
rights as advancing the drug industry’s interests overall, affecting
rich and poor nations alike. The United States can’t unilaterally change
the sticker price on drugs abroad, but Trump’s administration can
create a climate in which they are likely to rise.

“It’s
hilarious. Trump is a businessman, and every businessman knows you
charge what the market will bear,” said Suerie Moon, of the Global
Health Centre, Graduate Institute of International and Development
Studies in Geneva. “It’s a line that we have heard from [pharmaceutical]
lobby groups, that if European countries would pay more, that would be a
fairer situation, but I’ve rarely heard companies argue if Europe paid
more, the U.S. pays less." WHO to focus global attention on drug prices this month

Trump’s
policies may play out in trade pacts like a revised NAFTA agreement,
which is currently being negotiated, or in global forums like the World
Health Organization, which will take up drug pricing at its May 21
annual meeting. WHO has nearly 200 member countries, but the U.S., which
provides about a quarter of its budget, holds outsize sway.

Poorer
countries have long struggled to pay for the latest drugs, but nowadays
even richer Western European nations feel the pinch of five- and
six-figure price tags on treatments for diseases like hepatitis C or
cancer.

“The pharma pricing issue has really come to a breaking
point,” said Ellen ‘t Hoen of the University of Groningen in the
Netherlands and a former executive director of the Medicines Patent
Pool, which secures rights to produce cheap copycats of drugs for poor
countries. “There’s a real appetite for change.”

The White House
declined to comment before Trump’s speech except to refer to the
president’s past remarks and his administration’s economic reports.

U.S.
Office of the Trade Representative spokeswoman Emily Davis said the aim
is pharmaceutical trade policies that are transparent,
nondiscriminatory “and increase fair market access for American
innovators.” The White House Council of Economic Advisers issued a report in February that labeled “free-riding” from wealthy countries ”the root of the problem.”

Some
trade policies the administration has favored, like keeping generics
off the market longer than some public health experts advocate, could
actually reduce competition for pricey biologics for diseases like
cancer or rheumatoid arthritis. Delaying the marketing could also set
back the emerging biosimilar industry, meaning less access to cheaper
versions of these new therapies in the U.S. and abroad.

The
Trump administration has gone after Colombia and Malaysia for taking
steps that are legal under international agreements to skirt brand drug
patents when public health needs necessitate lower-cost medicines, a
forceful maneuver known as compulsory licensing, in which a country
basically voids a patent so a cheaper generic can be made. The White
House negotiated a South Korea trade deal that opened up its market to
U.S. drug-makers.

And the U.S. drug lobby PhRMA cheered Trump
for an April report from the U.S. trade office, which for the first time
devoted a section solely to pharmaceutical intellectual property
rights. The list did not ultimately include the European Union, despite
PhRMA’s request that it be put on notice ahead of proposed changes to
medical IP incentives, due later this month. However, the report
did name-and-shame more than a dozen countries — including close
partners like Japan and Canada — based on complaints about pharma patent
protections.

Researchers at the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center empirically tested Trump's claim
that the high U.S. prices are required to fund research and innovation.
They found that drug companies earn “substantially more” than what the
industry spends on R&D and concluded that drug-makers have room to
lower U.S. prices without raising them overseas, and still maintain
their R&D investments. Waiting for copycat medicines

And critics say Trump’s international pharmaceutical agenda could have ramifications at home.

The
“trade agenda doesn’t necessarily seem to be synced up with the access
to affordable medicines agenda,” said Jeff Francer, senior vice
president and general counsel of the Association for Accessible
Medicines, a generic drug lobby.

He notes that if a renegotiated
NAFTA deal grants pricey biologics 12 years of monopoly protection, not
only would Mexico and Canada have to wait longer for cheaper copycat
medicines but the U.S. wouldn’t be able to change its own law to get
biosimilars to market sooner. That 12-year standard was put in place in
Obamacare, but some Democrats have been pushing to shorten it.

Francer
also pointed out the risks in Trump’s proposal to slap billions of
tariffs on Chinese imports, including ingredients used to make finished
medicines like insulin, antibiotics and vaccines in the U.S. While many
financial analysts doubt the Chinese tariffs would have a big impact on
U.S. prices, they do worry that the U.S. could spread this policy to
countries like India that are more critical to the U.S. generic drug
industry. The administration has already criticized India
for imposing price caps on medical devices used to treat heart disease
and has said it is looking at whether to revoke special import status
India gets in the U.S. as a result.

President Donald Trump has brought the global pharmaceutical debate
into the domestic dialogue. He’s gone to the American people and blamed
other countries for high prices in a way that past presidents did not.